As part of its Data Management Centre Certification programme, ECRIN conducted an initial audit of the Medical Research Collaboration Center (MRCC) at Seoul National University Hospital in Seoul, South Korea, from January 13th to 17th, 2020.
Image: ECRIN audit closing meeting. ©ECRIN
This audit is the continuation of the pilot that was initiated in Japan in the fall of 2018 to globalise the Data Management Centre Certification programme.
ECRIN’s certification programme was developed to audit European, non-commercial data centres using ECRIN IT/DM standards, and to confirm their ability to provide compliant, effective, and efficient data management services for controlled clinical trials. The goal, in turn, is to enhance high-quality data management services in non-commercial clinical trials and to contribute to the harmonisation of European practice in data management. Since it was set up in 2014, 13 European data centres have been certified.
In 2018, it was decided to expand the programme beyond Europe. The goal is to have parallel programmes in academic data management centres within various regions of the world. One data management centre was certified last year in Japan.
Image: ECRIN's lead auditor (Christine Toneatti, middle) works with co-auditor (Michael Faherty), and two Korean observer auditors, along with others from the data management and IT team at MRCC. ©ECRIN